Responsible for the end-to-end execution and oversight of regulatory submissions across the company’s cell therapy portfolio.
Ensure high-quality, compliant, and timely regulatory submissions to global health authorities, including FDA, EMA, and other international agencies.
Leads planning, preparation, publishing, and lifecycle management of regulatory submissions (e.g., INDs, IMPDs, amendments, annual reports, meeting packages, BLAs/MAAs).
Manage submission timelines, content readiness, and cross-functional coordination to support regulatory milestones.
Develop, maintain, and optimize regulatory operations processes, SOPs, templates, and best practices.
Perform Regulatory Submission and Correspondence archival, ensuring version control, and inspection-ready documentation.
Provide support for Regulatory deliverables in GCP Inspection Readiness.
Partner closely with Regulatory Affairs strategy leads, CMC, Clinical Development, Medical Writing, Quality, and external vendors.
Support health authority interactions by preparing and managing briefing packages and response submissions.
Act as a subject matter expert in regulatory operations, advising on evolving global regulatory requirements and electronic submission standards.
Drive continuous improvement initiatives to enhance submission quality, speed, and scalability.

Requirements

Bachelor’s degree in life sciences or related field required; advanced degree preferred.
8+ years of regulatory operations experience in biotech or pharmaceutical industry.
Demonstrated experience supporting IND-stage, BLA/MAA, and marketed product submissions.
Prior experience in cell therapy, gene therapy, or other advanced therapies highly desirable.
Hands-on experience with eCTD publishing and regulatory systems (e.g., Veeva RIM, Vault, Lorenz DocuBridge, DXC Toolbox, Lorenz eValidator). Veeva Publishing experience preferred.
Strong document formatting expertise with hands-on experience utilizing Regulatory document templates (StartingPoint experience preferred).
Strong knowledge of FDA, EMA, and global regulatory submission requirements.
Highly organized with exceptional attention to detail and ability to manage multiple submissions in parallel.
Strong communication and cross-functional collaboration skills.
Comfortable operating in a fast-moving, evolving clinical-stage environment.
Proactive, solutions-oriented mindset with a strong sense of ownership.

Benefits

This position is also eligible for bonus
benefits
participation in Company’s stock option plan

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

regulatory submissionseCTD publishingdocument formattingregulatory operationssubmission timelines managementcontent readinessinspection-ready documentationcontinuous improvement initiativesSOPsbest practices

Soft skills

highly organizedattention to detailcommunication skillscross-functional collaborationproactive mindsetsolutions-orientedownershipability to manage multiple submissionsleadershipplanning